Type 2 Diabetes in Obese Children Proves Difficult to Treat with Drugs Alone

Type 2 Diabetes in Obese Children Proves Difficult to Treat with Drugs Alone

Metformin, "the only pill approved in the U.S. for treatment of children with type 2 diabetes is proving surprisingly ineffective, according to a new study, heightening worries about the fast-growing and largely preventable disease," reports the Wall Street Journal (see here).

The study also included GSK's Avnadia, which is not approved for use in children and has been linked to an increase of heart attacks, curtailing its use in treatment.

699 children between 10 and 17 years old, essentially all of whom were obese and who had been diagnosed with type 2 diabetes for an average of eight months were randomly assigned to one of three treatments: metformin, the mainstay diabetes medicine; metformin plus a lifestyle-intervention program; or metformin plus Avandia.

52% of those on metformin alone had failed, compared with 47% on metformin plus lifestyle change and 39% on the two-drug regimen. Statistically, only the two-drug treatment was considered superior to metformin.

The results prompted other experts to renew calls for societal efforts to combat diabetes and obesity among young people. Here is a chart showing the prevalence of obesity among young people in the U.S.:

Coincidentally (or maybe not), the National Institutes of Health (NIH) sent out a press release today announcing "The Weight of the Nation" documentary series and public awareness campaign focused on obesity in the U.S. HBO, in association with the Institute of Medicine, NIH and the Centers for Disease Control and Prevention, and in partnership with the Michael & Susan Dell Foundation and Kaiser Permanente Foundation, developed four documentaries focused on obesity. The project also includes a three-part HBO Family series for kids, 12 short features, a social media campaign, and a nationwide community-based campaign to mobilize action to move the country to a healthier weight. See the press release here.

Resurgence of Pharma Lobbying Spending

Resurgence of Pharma Lobbying Spending

According to Open Secrets, which tracks industry lobbying, "the pharmaceutical industry as a whole spent $69.6 million on lobbying in the first three months" of 2012 (see "Pharma, Utilities and Big Ag Lead Lobbying in 2012"). Included in that category are "Health products" other than Rx medicines. Looking at just "Pharmaceutical Manufacturers" (including PhRMA, the drug industry's U.S. trade association), the total lobbying spend in the first quarter of 2012 was $48.1 million.

Here's a chart of the biggest spenders in this category so far:

Annual pharmaceutical lobbying -- as measured in dollars -- increased more or less steadily since 1998, but peaked in 2009 at $186.1 million. If the spending in 2012 continues at the pace of the first three months, the pharmaceutical industry will spend approximately $192.4 million in lobbying for the year (see chart; the 2012 bar is projected as 4 X Q1).

Open Secrets contends that the pharmaceutical industry is "clearly focused on protecting the existing provisions of Medicare Part D, which subsidizes the cost of drugs. Critics in Congress have targeted the program for its huge cost, and some want it to be more transparent about how reimbursements are set. Also at issue," says Open Secrets, "is whether the government should be able to negotiate drug prices with the companies, something that is currently prohibited."

The pharmaceutical industry is keen on preventing changes to Medicare -- especially changes that would allow the government to negotiate prices. Back in October, 2011, the Campaign for Modern Medicines (@Modernmeds) and Eli Lilly & Company (@LillyPad) hosted at least one Tweetchat on Medicare Part D to "help raise awareness on the value of the current system, and to learn how to prevent potential changes to it" (see "More Pharma Twitter Chats: Medicare is Topic" and "Was Lilly's #mmeds Twitter Chat a Discussion or a Press Conference?").

Although it is difficult to link lobbying spending with specific bills in Congress, the drug industry -- especially through PhRMA -- is also lobbying hard to get a favorable PFUFA (FDA funding) bill passed (see, for example, "Angry PhRMA, Level 1: PDUFA").

Of course, 2012 is also a presidential election year and that will likely keep lobbying -- including donations to candidates and their political parties -- at a high level throughout the year. Here's some interesting data showing the trend in pharma donations by political party (see more such data here):

It seems that the drug industry was intent on getting Republicans elected in 2000 and 2002 and when that was accomplished, they cut back and reaped the benefits of the status quo, or as some would say the "do nothing" Congress.

Novo Nordisk is Back on Pinterest with Patient Stories

Novo Nordisk is Back on Pinterest with Patient Stories

Novo Nordisk is back on Pinterest! Recall that Novo "de-pinned" all its images a few days after I first discovered them on Pinterest (see "Pharma Pinterest Update: Bayer US Pins, Novo Nordisk Depins!"). Novo now has 3 "boards" and 15 images on the site.

The most interesting "board" is the one devoted to "Patient Stories." The images pinned to this board link to videos that feature narratives spoken by real patients who suffer from various forms of diabetes. Here are the images:

NOTE: Novo is smart to use videos that are viewable on iPhones and iPads. In a previous post I noted that Janssen Uses Digital Storytelling, Animation to "Bring Prescription Medicine Labeling to Life." But Not iPhone or iPad Life!

This, I believe, is a very good use of Pinterest by a pharmaceutical company and I expect others to follow Novo's lead. I am sure, however, that everyone is waiting to see what mischief will befall Novo. So to hurry this process along, I did two things:

• I reported one pin to Pinterest and "complained" that it lead to a "drug site."
• I added a comment to another pin asking Novo if the patient was paid to participate in the video.

I'm a trouble-maker, I know. But someone has to test pharma's use of Pinterest. Let's see if they pass the Pharmaguy Stress Test.

Currently, there is a lot of worry about spammers using Pinterest. Spam pins, for example, link to pages that only contain Google Adwords. Pinterest is trying to deal with this, but many people, like myself are becoming victims of their over zealousness.

Every one of my pins that has a link in the comment section is "blocked" by Pinterest when users click on the link. Pinterest says that the pin has been "reported" as being spam or leading to "objectionable content." All the links are to this blog.

I doubt that Pinterest has bothered to investigate "reports" to determine if they are legitimate or not. They are simply "blocking first and asking questions later." Actually, Pinterest doesn't even tell you that you are being blocked and they certainly haven't asked me any questions about whether or not I am a spammer.

So, I am testing Pinterest by reporting one of Novo's pins.

As I mentioned in the previous post cited above, comments are Pinterest's Achilles heel as far as pharma companies are concerned. It's as easy to make comments on Pinterest as it is on Facebook. We have seen how pharma has run away from Facebook because comments cannot be turned off. Will the same happen with Pinterest?

Meanwhile, you might be interested in taking the following survey. Afterward. you'll be able to view a de-identified summary of results:

Create your free online surveys with SurveyMonkey, the world's leading questionnaire tool.

Device Makers, e.g. Johnson & Johnson, May Benefit Most from FDA User Fee Bill

Device Makers, e.g. Johnson & Johnson, May Benefit Most from FDA User Fee Bill

"Put simply," says AdvaMed, the trade association of the medical device industry, "the [user fee agreement recently reached between FDA and the medical technology industry] is good for FDA; it is good for industry; and most of all, it is good for American patients."

The House version of the FDA user fee bill, which is currently being marked up, is "widely expected to contain more industry-friendly provisions, especially for medical device makers," according to Politico (here).

"One in particular is the HELP bill’s efforts to streamline the FDA’s ability to reclassify the risk level of devices. Whether a device is deemed more, or less, risky can dramatically change the amount of clinical data and other studies required for approval.

"Currently, such reclassification is a long-term rulemaking process that must be cleared by Health and Human Services and the Office of Management and Budget along with the full complement of public hearings and comment periods. The HELP bill would turn that into a faster administrative process without the extra layers of oversight."

According to Politico, AdvaMed is still pushing something in between "to preserve some of our due process rights,” AdvaMed's head of government relations (ie, chief lobbyist).

Details of "FDA’s ability to reclassify the risk level of devices" may be hidden in the bills. One of these details may concern "a loophole in the law that allows [medical device manufacturers] to submit new products to the FDA for instant review as long as they classify them as an upgrade even if the product has changes that could affect safety," says Consumer Reports. "Companies now use the process 90 percent of the time, according to a report published by Rep. Ed Markey, D-Mass., who is an advocate for industry reform."

Meanwhile, the FDA wants to assign a new bar-code-like identification number to medical devices to help it detect malfunctions in devices AFTER they have been approved. By tapping into medical and billing records from hospitals and insurance companies, FDA hopes to identify faulty devices before they cause deaths, such as the 686 deaths from 2009 to last year connected to automated external defibrillators and at least 20 deaths recently linked to surgically-implanted heart defibrillator wires.

One of the leading manufacturers of heart defibrillation devices is Guidant. A few years ago, it had to recall one of its devices that was linked to several deaths (see NYT article). That derailed a takeover bid by Johnson and Johnson (JNJ). Meanwhile, JNJ is actively growing its medical device business and will soon acquire Synthes -- a Swiss manufacturer of orthopaedic devices -- for $21.3 billion. Devices now account for 40% of JNJ's worldwide sales (see chart below; source of data: CNNMoney.com and Q1 2012 financial statement).

JNJ may position itself as a "consumer" products company, but its  main business is pharmaceutical drugs and medical devices. With the acquisition of Synthes, which had sales of nearly $4 billion last year, JNJ's device business will be an even bigger slice of its global sales pie (maybe 43%).